1. Field of Technology
The present application relates generally to clinical trial systems. More specifically, the present application is directed to a distributed clinical trial system that provides configurability, reusability and integration of randomization and inventory management configurations for different clinical trials with various electronic data capture (EDC) systems.
2. Brief Description of Related Art
A clinical trial is performed to, among other things, test the safety and efficacy of a new drug or treatment (e.g., therapy), and ultimately, to ascertain whether or not a therapy is appropriate for widespread human consumption.
There are generally four phases in the clinical trial. In Phase I, a few subjects (approximately 20 to 100) are used to determine toxicity of the therapy. In Phase II, more subjects (approximately 20-300) are used to determine efficacy and further ascertain safety of the therapy. In Phase III, hundreds to thousands of subjects are used to obtain meaningful statistical analysis of the therapy's efficacy. The treatment may be compared to either a placebo or another existing therapy. In Phase IV (post-approval of clinical trial), more testing is performed to evaluate long-term effects and to evaluate other indications of the therapy.
In a comparative clinical trial, subjects are assigned to multiple arms in order to facilitate analysis in a comparative fashion. For example, subjects assigned to one arm (e.g., “control”) can receive a placebo, while subjects assigned to another arm can receive the medication being tested. Comparing the results of the therapy in each arm of a multi-arm clinical trial provides a measure of the efficacy of the medication in testing the effectiveness of the medication. In another example, arms can also receive various dosages of the medication being tested to evaluate the safety and efficacy of the dosages. Still in other examples, some arms can receive another medication against which the safety and efficacy of the medication being tested can be evaluated.
The subjects of the multi-arm clinical trial are generally randomized (e.g., assigned to the arms of the multi-arm clinical trial in a random fashion) to avoid biases that may occur in the selection of subjects for the clinical trial. A bias can be introduced if a subject who is a particularly well-suited to respond to a new medication—based on certain prognostic factors (e.g., sex, age, prior condition or other factor)—is intentionally assigned to an arm that receives the medication being tested and not an arm that receives a placebo. This could skew the statistical analysis and the outcome of the clinical trial to favor the medication being tested.
A bias can further be introduced unintentionally if more subjects having certain prognostic factors are randomly, but unevenly, assigned to one arm versus another arm of the clinical trial. Some clinical trials have attempted to mitigate this bias by attempting to balance certain factors across the arms of the clinical trial.
To further mitigate the risk of bias, the multi-arm clinical trials are generally single-blinded or double-blinded. The single-blinded clinical trial does not reveal the arm assignment to the subject, while the double-blinded clinical trial does not reveal the arm assignment to the subject and to the investigator. Most randomized clinical trials are blinded.
There are currently a number of categories of computerized clinical trial management systems that facilitate different aspects of the clinical trial. A first category includes an interactive voice-response (IVR) system or interactive-web-response (IWR) system. Systems in this category typically facilitate enrolment of multiple subjects into a clinical trial and the dispensing of medication during the clinical trial. A second category includes an electronic data capture (EDC). Systems in this category typically capture clinical information concerning the subjects during the clinical trial.
In most clinical trials, the foregoing systems in these two categories are separate and not integrated. In some cases, where integration has been effected, the EDC receives information concerning the enrolled subjects from the IVR/IWR and randomizes the subjects into arms of the clinical trial. The EDC may also receive information from the IVR/IWR concerning medication that is administered to the subjects during visits of the clinical trial. The second system maintains the received information and other information concerning the clinical trial in a runtime database. Upon completion of the clinical trial, the maintained information is closed out and used to evaluate the medication tested in the clinical trial.
Typically, a designer writes a specification for the IVR or IWR according to the requirements of a particular clinical trial. Thereafter, a developer generally hard-codes or programs the IVR/IWR for the clinical trial in accordance with the specification. Subsequent revisions to the specification of the clinical trial require recoding of the IVR/IWR. While there has been some integration in clinical trial management, a clinical trial management system that enables configurability, reusability and integration of randomization and dispensing of medication across different trials and various EDCs has remained illusive.